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Job Information

Labcorp Associate Director, Biostatistics in Durham, North Carolina

Job Overview:

Hiring for Associate Director, Biostatistics (Remote) FSP: can be based anywhere in USA/ Canada #LI-REMOTE

  • Lead complex studies such as NDA submission or complex, multi-protocol programs, potentially coordinating activities across multiple locations, providing statistical oversight and attending relevant project meetings.

  • Perform project management activities for identified projects including resource planning, timelines and milestone management.

  • Attend bid defense meetings for complex studies such as NDA submissions or complex, multi-protocol programs in order to win new business.

  • Serve as DMC Support Statistician, developing DMC Charters and attending DMC Meetings

  • Lead the development of complex Statistical Analysis Plans, perform senior review of statistical analysis plans developed by other statisticians.

  • Perform complex statistical analyses; quality check statistical analyses developed by other statisticians.

  • Coordinate overall statistical review of TFLs for complex studies prior to client delivery

  • Review CRF and other study specific specifications and plans.

  • Perform complex sample size calculations.

  • Develop the statistical sections of the protocol for complex studies.

  • Provide statistical input and review of the CSR for complex studies.

  • Preparation and review of randomization specifications and generation of randomization schedules.

  • Provide mentoring and training to less experienced staff; provide direction and review work of departmental employees to ensure accuracy and adherence to pertinent departmental policies, practices, and procedures.

  • Present and share knowledge at monthly seminars and /or team meetings and at external scientific meetings and conferences.

  • Act as Subject Matter Expert and develop or review procedural documents, or work on new initiatives.

  • Advise on and coordinate biostatistical aspects of submissions to regulatory authorities; participate in presentations to regulatory reviewers.

  • Participates in internal and client audits, and regulatory inspections.

  • Proactively lead, review and amend departmental processes and documentation.

  • Establish and maintain client relationships and implement appropriate action plans based on client feedback.

Education/Qualifications:

Minimum required:

  • Master’s degree, equivalent, or higher in Biostatistics or related field

Experience:

Minimum required:

  • Minimum 12 + years of experience, or an equivalent combination of education or experience to successfully perform the key responsibilities of the job.

  • SAS proficiency including use of a variety of statistical procedures, e.g., non-parametric analysis, linear and non-linear models, categorical data and survival analysis.

  • Full knowledge of the interactions required by a biostatistician throughout the lifespan of a trial; a substantial knowledge of the responsibilities of those departments with whom biostatisticians and statistical programmers interact.

  • Excellent problem solving skills, and a willingness to take ownership of decision-making.

  • Interpersonal and effective communication skills; able to communicate appropriately throughout Covance by Labcorp and with its clients.

  • A substantial knowledge of the overall clinical trial process and of its application within Covance by Labcorp Clinical Development.

  • Competence in the preparation of Statistical Analysis Plans, analysis, reporting, etc., across a variety of trials.

  • A broad up-to-date knowledge of statistics as applied in clinical trials across therapeutic areas.

  • Demonstrates good knowledge of clinical research guidance, including Food and Drug Administration (FDA), international regulatory agencies, international conference on harmonization (ICH), and good clinical practice (GCP).

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